Urinary incontinence, such as stress incontinence, in females is a substantial problem throughout the world. A variety of mechanisms have been suggested for use to alleviate the condition which can be a social as well as medical problem for those so afflicted.
Many suggested medical devices to alleviate urinary incontinence in females require the use of internal components such as catheters, balloons, pessary or the like which pass into the urethra and are positioned within the body in use. Such internal components can be a source of irritation to the body, thereby causing discomfort to the user and, in some cases, can result in an unwanted body reaction, such as an infection. In addition, such devices as are known, can be expensive and/or inconvenient to use and transport for use.
More recently, a urethral cap has been used for alleviating urinary incontinence, which cap overcomes many of the afore-mentioned problems associated with conventional medical devices. In use, the urethral cap is positioned exterior to the body and utilizes atmospheric pressure to create a vacuum in order to maintain the cap in position on the body of the user. The cap has been shown to be helpful in many cases to alleviate urinary incontinence in females, thereby providing the user with an inexpensive device which is easy to transport, simple to apply and remove and which is unlikely to cause infection in the user when properly used.
In order to provide the user with a device resistant to collapse or deformation by atmospheric pressure, previous designed urethral caps were provided with walls of certain thickness. While providing a comfortable fit for many women, the predetermined thickness decreased the flexibility, i.e. the compliance or softness of the device, thereby sometimes causing discomfort, and hence irritation, in some women. In addition, previously designed caps often included a generally circular flange which has also been found to cause discomfort in some user due to its geometric configuration.
There is therefore needed an improved urethral cap which provides increased comfort to a wide range of users while maintaining the integrity of the device.